Can Rotavirus Vaccines Cause Injury and Death?
Vaccines are pharmaceutical products and, like all pharmaceutical products, carry a biological risk of injury or death that can be greater for some than others. The risk for injury or death from vaccination depends upon the vaccine(s) given and the individual’s health at time of vaccination, vaccine reaction history, and personal or family medical history.
There is a gap in medical knowledge in terms of predicting who will have an adverse reaction to vaccination, including reactions to the rotavirus vaccine, and who will not.1
Vaccine Reactions and Injuries
According to the CDC, mild vomiting and diarrhea, as well as irritability can occur after rotavirus vaccine administration. The use of rotavirus vaccines is also associated with an increased risk of intussusception, a serious blockage of the bowel requiring medical attention and that may require surgical intervention. The CDC estimates that this increased risk of intussusception occurs within the first week post-vaccination of the first or second vaccine dose at a rate between one in 20,000 and one in 100,000 infants who receive the vaccine.2
The CDC also acknowledges the presence of porcine circovirus DNA in the rotavirus vaccines, but reports that there are no known safety concerns involving the contaminants and that the viruses do not infect people.3
Adverse events reported by Merck in the vaccine package insert for RotaTeq live rotavirus vaccine include:4
- Commonly Reported Adverse Events: Vomiting, diarrhea, and irritability, fever, otitis media, nasopharyngitis, and bronchospasm.
- Serious Reported Adverse Events: Intussusception, bronchiolitis, pneumonia, fever, gastroenteritis, urinary tract infection, hematochezia (fresh blood in the stool), seizures, Kawasaki disease, anaphylactic reaction, urticaria, angioedema, and death.
Adverse events reported by GlaxoSmithKline in the vaccine package insert for ROTARIX live rotavirus vaccine include:5
- Commonly Reported Adverse Events: Diarrhea, fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.
- Serious Reported Adverse Events: Intussusception, Kawasaki Disease, hematochezia, gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID), idiopathic thrombocytopenic purpura, convulsions, pneumonia and death.
The most commonly reported serious adverse reaction associated with rotavirus vaccines is intussusception. Intussusception occurs when one part of the intestine pulls inward into itself and can block food from passing through the intestine. If blood supply to the affected part of the intestine occurs, death of that segment of the intestine may occur. Additionally, if a hole occurs in the intestine, this can lead to infection, dehydration, shock and can be life-threatening.6 7
In 1998, the first rotavirus vaccine, RotaShield, received FDA approval for use and was recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP) for use in infants; however, by July 1999, multiple reports of intussusception following vaccine administration had been reported to the Vaccine Adverse Events Reporting System (VAERS). Because of this safety signal, the CDC recommended that RotaShield not be used until November 1999 and that parents of recently vaccinated infants call their health care provider immediately should symptoms of intussusception present in their infants.8 On October 22, 1999, ACIP voted to stop the use of RotaShield and the vaccine was withdrawn from the market by the manufacturer.9
Both RotaTeq and ROTARIX, the two rotavirus vaccines available for use in the U.S. can cause intussusception. The federal government acknowledges intussusception occurring between one- and 21-days after the first or second dose of rotavirus vaccine as a vaccine injury and has included this on the Vaccine Injury Table.10
In addition to intussusception, rotavirus vaccines have also been associated with Kawasaki Disease, a childhood disease which causes inflammation of the walls of the body’s blood vessels. Specifically, in the phase 3 licensing clinical trials of RotaTeq, rates of Kawasaki Disease within 42 days of vaccine administration were higher among infants who received the vaccine in comparison to those who did not. Published case studies and reports of Kawasaki Disease post RotaTeq vaccination have also been reported to the Vaccine Adverse Events Reporting System (VAERS) post-licensure. Some studies, however, have not found an increased risk of Kawasaki Disease post rotavirus vaccine administration.11 12
On March 22, 2010, the FDA announced that it has become aware that an independent U.S. academic research team had found DNA from porcine circovirus 1 (PCV1) in the ROTARIX vaccine. The FDA recommended that healthcare practitioners temporarily suspend use of ROTARIX vaccine in the U.S. while the agency learned more about PCV1; however, they reported that this finding posed no safety concerns and stated that PCV1 was not known to cause illness in humans or other animals.13 On May 14, 2010, the FDA announced that they had reviewed the scientific evidence and determined that the vaccine was safe and use of the product should continue.14 PCV1 remains a contaminant of the ROTARIX vaccine.15
On May 7, 2010, the FDA announced that RotaTeq vaccine was contaminated with DNA from two porcine circoviruses: PCV1 and PCV2. Although PCV1 had not been associated with clinical disease in pigs, PCV2 was known to be a lethal pig virus that caused immune suppression and a serious wasting disease in baby pigs that damages lungs, kidneys, the reproductive system, brain and ultimately causes death. The FDA recommended temporary suspension of the use of ROTARIX vaccine on March 22, 2010 after DNA from PCV1 was identified in ROTARIX but did not call for suspension of the use of RotaTeq vaccine after PCV2 was found in RotaTeq.16 To date, PCV1 and PCV2 continue to contaminate RotaTeq vaccines.17
Reported Vaccine Reactions and Injury Compensation
Using the MedAlerts search engine, as of February 28, 2021, there have been 33,016 adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with rotavirus vaccines. Of these reported adverse events, 10,469 were listed as serious and 841 were deaths.
Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between one and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials, who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.18 19 20 21
As of April 1, 2021, there have been 117 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following rotavirus vaccination, including six deaths and 111 serious injuries. Of that number, the U.S. Court of Claims administering the VICP has compensated 69 children who have filed claims for rotavirus vaccine injury.
IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
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1 Institute of Medicine. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. The National Academies Press 2013.
2 U.S. Centers for Disease Control and Prevention. Rotavirus VIS. In: Vaccine Information Statements (VISs). Oct. 30, 2019.
3 U.S. Centers for Disease Control and Prevention. Rotavirus VIS. In: Vaccine Information Statements (VISs). Oct. 30, 2019.
4 Merck Sharp & Dohme Corp. RotaTeq – Label. U.S. Food and Drug Administration. Aug 17, 2020.
5 GlaxoSmithKline Biologicals. Package Insert and Patient Information – Rotarix. U.S. Food and Drug Administration Dec. 12, 2019.
6 Medline Plus. Intussusception – children. In: Medical Encyclopedia. Jan. 5, 2021
7 U.S. Centers for Disease Control and Prevention. Symptoms In: Rotavirus. Mar. 26, 2021.
8 U.S. Centers for Disease Control and Prevention. Intussusception Among Recipients of Rotavirus Vaccine —United States, 1998–1999. MMWR July 16, 1999; 48(27): 577-581.
9 Centers for Disease Control. Recommended Childhood Immunization Schedule – United States, 2000 MMWR Jan. 21, 2000; 49(2): 35.
10 Health Resources & Services Administration (HRSA). Vaccine Injury Table (Revised and Effective March 21, 2017). Mar. 21, 2017.
11 Chang A, Islam S. Kawasaki disease and vasculitis associated with immunization. Pediatr Int July 2018; 60(7):613-617.
12 Geier DA, King PG, Sykes LK, et al. RotaTeq vaccine adverse events and policy considerations. Med Sci Monit. 2008;14(3):PH9–PH16.
13 Schrinning L. FDA urges clinicians to suspend use of GSK rotavirus vaccine. CIDRAP News. Mar. 22, 2010.
14 U.S. Food and Drug Administration. Information for Parents and Caregivers In: Vaccines, Blood, and Biologics. May 14, 2010.
15 Communication and Education Branch, National Center for Immunization and Respiratory Diseases (NCIRD) and the Centers for Disease Control (CDC). Appendix B: Vaccine Excipient Summary - Excipients included in U.S. Vaccines, by Vaccine In: Epidemiology and Prevention of Vaccine-Preventable Diseases. February 2020.
16 Schnirring L. Second rotavirus vaccine found to contain porcine circovirus. CIDRAP News. May 7, 2010.
17 Communication and Education Branch, National Center for Immunization and Respiratory Diseases (NCIRD) and the Centers for Disease Control (CDC). Appendix B: Vaccine Excipient Summary - Excipients included in U.S. Vaccines, by Vaccine In: Epidemiology and Prevention of Vaccine-Preventable Diseases. February 2020.
18 Kessler DA, the Working Group, Natanblut S, et al. A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. JAMA 1993; 269(21):2765-2768.
19 FDA.gov. Kessler DA. Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. JAMA June 9, 1993.
20 Rosenthanl S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85: pp. 1706-9.
21 AHRQ Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS). Dec. 1, 2007-Sep. 30, 2010.